Osteoporosis Prevention Program: Phase II Results

Tarsa has completed a successful Phase II trial of its once-daily oral calcitonin in the prevention of postmenopausal osteoporosis. The Phase II prevention trial was a randomized, double-blind, placebo-controlled study designed to evaluate the ability of Tarsa’s TBRIATM to improve bone mineral density (BMD) at the lumbar spine in postmenopausal women with low bone mass (osteopenia), who are at increased risk of fracture. TBRIA was superior to placebo in increasing BMD at the lumbar spine in this population, and its safety profile did not differ substantially from placebo [1]. The most commonly reported adverse events were gastrointestinal and respiratory infection, and occurred with a similar frequency in both groups.

The Phase II prevention trial was conducted at multiple clinical centers in the U.S. The results of this trial were presented at the American Society for Bone and Mineral Research 2012 Annual Meeting, and subsequently in a peer reviewed journal, Osteoporosis International.

[1] Binkley N, Bone H, Gilligan JP, Krause D. Efficacy and safety of oral recombinant salmon calcitonin tablets in postmenopausal women with low bone mass and increased fracture risk: a randomized, placebo-controlled trial.  Osteopor Int 2014. DOI 10.1007/s00198-014-2796-0